Clinical Trial of TQH2722 Injection in Patients With Seasonal Allergic Rhinitis

NCT06760182 | Completed Phase 2

• 1 other identifier: TQH2722-II-05
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 30

Brief Summary

To evaluate TQH2722 injection in all patients receiving background treatment with mometasone furoate nasal spray (MFNS) and loratadine. The efficacy, safety and immunogenicity of the solution in patients with seasonal allergic rhinitis compared with placebo are expected to include 168 patients with confirmed seasonal allergic rhinitis (SAR) who have failed to respond to standard treatments.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Retrospective nasal symptom score after treatment for 2 weeks

  Average daily retrospective nasal symptom score (rTNSS) changed from baseline after 2 weeks of treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms.

  Baseline up to 2 weeks

Secondary Outcomes (25)

• Retrospective nasal symptom score after treatment for 4 weeks

  Baseline up to 4 weeks

• Mean daily changes in retrospective nasal symptom total score

  Baseline up to 2 and 4 weeks

• Mean daily nightly retrospective nasal symptom total score

  Baseline up to 2 and 4 weeks

• Instantaneous nasal symptom score: Mean change of instantaneous nasal symptom total score (iTNSS) from baseline

  Baseline up to 2 and 4 weeks

• Instantaneous nasal symptom score: Mean daily rTNSS change from baseline

  Baseline up to 2 and 4 weeks

Study Arms (2)

TQH2722 injection

EXPERIMENTAL

Drug: TQH2722 injection

TQH2722 Placebo

PLACEBO COMPARATOR

TQH2722 placebo, 1 weeks as a treatment cycle.

Drug: TQH2722 Placebo

Interventions

TQH2722 injection DRUG

TQH2722 injection is a humanized monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα).

TQH2722 injection

TQH2722 Placebo DRUG

Placebo without drug substance.

TQH2722 Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years at the screening period.
• Patients who met the diagnostic criteria of allergic rhinitis in Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (revised edition, 2022)
• Positive of at least 1 allergen skin prick test(SPT) and/or serum-specific IgE within 1 year before enrollment.
• Subjects have sufficient pollen exposure during the pollen season:
• Subjects' medical history suggested that SAR symptoms were poorly controlled or subjects' subjective symptoms were not satisfactorily controlled after drug treatment during the same pollen season in the past.
• On the day of screening, the iTNSS score in the morning was ≥4; At baseline visit, the morning iTNSS was ≥4 points, and the average score of the past 6 rTNSS was ≥6 points;
• At baseline visit, the absolute value of peripheral blood eosinophils was ≥0.15×109/L;
• During the screening/induction period, the subjects had good compliance;
• Subjects with asthma who were assessed by the investigator or specialist as having stable asthma;
• Voluntary participation in this trial and signing the informed consent form
• Subjects (including partners) have no pregnancy and voluntarily take one or more non-pharmaceutical measures for contraception at period from drug administration to 6 months after the last study drug administration

You may not qualify if:

• Laboratory test values did not meet the requirements during screening or randomization
• Any disease that the investigator believes interferes with the patient's ability to complete the entire course of the study;
• Patients with active autoimmune disease
• People with known or suspected immunosuppression
• Subjects with active malignancy or a history of malignancy;
• Active hepatitis or hepatitis B was present during the screening period; Or human immunodeficiency virus antibody (Anti-HIV) positive, or treponema pallidum antibody (Anti-TP) positive;
• Diagnosis of helminthic infection within 6 months prior to screening, not receiving standard treatment or not responding to standard treatment;
• Subjects who have undergone nasal surgery or sinus surgery within 6 months before screening
• Subjects have concomitant medical conditions that preclude them from completing the screening period assessment or evaluating the primary efficacy endpoint;
• Subjects with nasal malignancies and benign tumors;
• History of hypersensitivity to any content of the study drugs or its excipients
• Subjects with a history of systemic allergy to any biological agent;
• Pregnant or lactating women;
• Alcohol, drug and known drug dependence;
• Have a history of vital organ transplantation or hematopoietic stem cell/bone marrow transplantation;

Sponsors & Collaborators

• Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.: lead

Study Sites (30)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Gansu Provincial Hospital

Lanzhou, Gansu, 730000, China

Location

Cangzhou Central Hospital

Cangzhou, Hebei, 061017, China

Location

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, 50000, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Location

The Central Hospital of Wuhan

Wuhan, Hubei, 430014, China

Location

Union Hospital, Tongji Medical College, Huazhong University of science and technology

Wuhan, Hubei, 430022, China

Location

Tongji Hospital of Tongji medical college of HUST

Wuhan, Hubei, 430030, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Baotou Central Hospital

Baotou, Inner Mongolia, 014000, China

Location

Chifeng Municipal Hospital

Chifeng, Inner Mongolia, 024005, China

Location

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 015000, China

Location

Ansteel Group General hospital

Anshan, Liaoning, 114000, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

Liaoning Health Industry Group Iron Coal General Hospital

Tieling, Liaoning, 112700, China

Location

The First People's Hospital of Yinchuan

Yinchuan, Ningxia, 750000, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710004, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Shandong Second Provincial General Hospital

Jinan, Shandong, 250000, China

Location

Qilu Hospital of Shandong University

Qilu, Shandong, 250012, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

Location

Zibo Central Hospital

Zibo, Shandong, 255036, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030000, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300041, China

Location

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300121, China

Location

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 300192, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 6, 2025
• Study Start: March 10, 2025
• Primary Completion: April 30, 2025
• Study Completion: July 1, 2025
• Last Updated: August 12, 2025

Record last verified: 2024-10

Locations

CN (30)